News

US FDA approves syringe version of Argenx's immune disorder drug
The U.S. Food and Drug Administration has approved a prefilled syringe version of Netherlands-based Argenx SE's blockbuster ...
Novavax says ‘no official response’ from FDA on BLA status for COVID shot
In an emailed statement to The Fly, Novavax (NVAX) said, “As we have previously stated, we believe that our Biologics License Application for ...
Infectious Disease Advisor6d
FDA Delays Final Approval of Novavax COVID-19 Vaccine
The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, according to KFF Health News, are also pressing regulators to revoke federal ...
CNN7d
Anti-vaccine sentiment may derail vaccines already awaiting FDA approval, experts fear
The surprise delay is casting new uncertainty on the fate of another vaccine awaiting FDA action: Moderna’s next-generation ...
HHS Secretary Kennedy consoles Texas family following child's measles death
Health and Human Services Secretary Robert F. Kennedy told people gathered at a funeral for a second child in Texas who died ...
Health and Me on MSN10d
FDA Delays Approval Of Novavax COVID-19 Vaccine
The delay follows leadership changes within the FDA. Dr. Scott Steele has been appointed acting director of the agency’s ...
Dramatic HHS cuts leave US ‘weaker as a nation,’ says top FDA vaccine official forced out under Kennedy
Sweeping job cuts and reorganizations taking place at the US Department of Health and Human Services under Secretary Robert F ...
Ousted Vaccine Official Says Kennedy Sought Data to Justify Anti-Science Stance, WSJ Reports
(Reuters) -Peter Marks, the FDA's top vaccine official ousted by Robert F. Kennedy Jr. said the U.S. health secretary's team ...
'Decapitated': More top vaccine regulators out at FDA, threatening new approvals
More top vaccine regulators at the FDA have either left or been forced out, which could hobble the agency's ability to ...
FDA Punts on Major Covid-19 Vaccine Decision After Ouster of Top Official
The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.
Targeted Oncology13d
FDA Oncology Actions: March 2025 Approvals and Designations
On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell therapy, for the treatment of pediatric and adult patients with ...